Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SGN-35 · 2 trials · 11 indications
Response rate is percentage of participants with skin lesions that express CD30+ receiving SGN-35 in primary cutaneous ALCL, MF, and extensive lymphomatoid papulosis whose best response during the observation period is a Partial Response (PR), regression of measurable disease, or Complete Response (CR), complete disappearance of all clinical evidence of disease, (i.e. at least moderate improvement). Objective tumor response (PR, CR, PR+CR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
| Arm | Type | Description |
|---|---|---|
| SGN-35 | EXPERIMENTAL | 1.8 mg/kg intravenously Day 1 of 21-day cycle. |
| A | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SGN-35 | DRUG | 1.8 mg/kg administered by outpatient IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. |
Inclusion Criteria: 1. Patients must have a biopsy confirmed diagnosis based on a combination of histological and clinical criteria of CD30+ lymphomatoid papulosis, CD30+ primary cutaneous anaplastic large T-cell lymphoma (pc-ALCL), or CD30+ mycosis fungoides for the phase II trial. There is no spe...
SGN-35 is an investigational oncology drug being studied for CD-30 positive anaplastic large T-cell cutaneous lymphoma and non-Hodgkin lymphoma. It is currently in Phase 2 clinical development for these CD-30 positive lymphoproliferative disorders, including mycosis fungoides and lymphomatoid papulosis.
SGN-35 is being developed by Pfizer, Inc. (NYSE: PFE). The drug is currently in Phase 2 clinical trials for CD-30 positive lymphomas and related conditions.
SGN-35 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial is active but not recruiting participants, and a Phase 1 trial has been completed.
SGN-35 has one active Phase 2 trial, NCT01352520, studying the drug in CD-30 positive lymphoproliferative disorders including anaplastic large cell lymphoma, mycosis fungoides, and lymphomatoid papulosis. A completed Phase 1 trial, NCT00430846, evaluated SGN-35 in CD30 positive hematologic malignancies.
SGN-35 is also known as brentuximab vedotin. It is an antibody-drug conjugate targeting CD30, which is expressed on malignant cells in certain lymphomas. The drug is being studied for CD-30 positive anaplastic large T-cell cutaneous lymphoma and non-Hodgkin lymphoma.